Bottom Line:
In 5 years of experience with the technique, no significant complications or device extrusion were observed except for two revision surgeries requiring FMT repositioning.It is concluded that direct round window stimulation without interposed fascia is an alternative for patients with hearing impairment caused by chronic otitis media and/or lack of ossicles, especially after modified radical mastoidectomy.It allows good results in a selected group of patients, although further observation on a larger population is needed to confirm long-term validity and effectiveness.

ABSTRACTThe objective of this study was to present 5 years of surgical experience, and the extended results of hearing preservation (based on 3-year follow-up), with the Med-El Vibrant Soundbridge (VSB) in which the floating mass transducer (FMT) is placed directly against the round window membrane, and the fascia is used only as covering tissue to keep it in position. A retrospective survey of surgical and audiological data was conducted to evaluate the performance and stability of patient hearing, with audiometric measurements performed over fixed time intervals up to 36 months. 21 patients, aged 19-62 years (mean 48.4), with mixed or conductive, bilateral or unilateral hearing loss were included in this study. Surgical intervention involved monaural implantation of the Med-El VSB between 2006 and 2009. The results were assessed using pure tone audiometry. In 5 years of experience with the technique, no significant complications or device extrusion were observed except for two revision surgeries requiring FMT repositioning. In the 3-year follow-up, we observed stable hearing in the implanted ear. It is concluded that direct round window stimulation without interposed fascia is an alternative for patients with hearing impairment caused by chronic otitis media and/or lack of ossicles, especially after modified radical mastoidectomy. It allows good results in a selected group of patients, although further observation on a larger population is needed to confirm long-term validity and effectiveness.

Fig3: Mean pre and postoperative BC thresholds in the operated ear (a) and opposite ear (b) over fixed time intervals. The bars show 0.95 confidence interval

Mentions:
Over the fixed time intervals, postoperative BC thresholds in the implanted ear were stable for most frequencies. However, statistical differences between BC thresholds were observed for interval I vs. pre for 2,000 Hz (p = 0.043) and 4,000 Hz (p = 0.015), and between interval II vs. pre for 4,000 Hz (p = 0.03). Comparison of hearing for BC thresholds before and 36 months after direct placement of FMT against the RW showed no statistically significant differences for all tested frequencies (Fig. 3). In the opposite ear, BC thresholds were stable over the whole frequency range during the 36-month follow-up period, confirming threshold stability (Fig. 4).Fig. 3

Fig3: Mean pre and postoperative BC thresholds in the operated ear (a) and opposite ear (b) over fixed time intervals. The bars show 0.95 confidence interval

Mentions:
Over the fixed time intervals, postoperative BC thresholds in the implanted ear were stable for most frequencies. However, statistical differences between BC thresholds were observed for interval I vs. pre for 2,000 Hz (p = 0.043) and 4,000 Hz (p = 0.015), and between interval II vs. pre for 4,000 Hz (p = 0.03). Comparison of hearing for BC thresholds before and 36 months after direct placement of FMT against the RW showed no statistically significant differences for all tested frequencies (Fig. 3). In the opposite ear, BC thresholds were stable over the whole frequency range during the 36-month follow-up period, confirming threshold stability (Fig. 4).Fig. 3

Bottom Line:
In 5 years of experience with the technique, no significant complications or device extrusion were observed except for two revision surgeries requiring FMT repositioning.It is concluded that direct round window stimulation without interposed fascia is an alternative for patients with hearing impairment caused by chronic otitis media and/or lack of ossicles, especially after modified radical mastoidectomy.It allows good results in a selected group of patients, although further observation on a larger population is needed to confirm long-term validity and effectiveness.

ABSTRACTThe objective of this study was to present 5 years of surgical experience, and the extended results of hearing preservation (based on 3-year follow-up), with the Med-El Vibrant Soundbridge (VSB) in which the floating mass transducer (FMT) is placed directly against the round window membrane, and the fascia is used only as covering tissue to keep it in position. A retrospective survey of surgical and audiological data was conducted to evaluate the performance and stability of patient hearing, with audiometric measurements performed over fixed time intervals up to 36 months. 21 patients, aged 19-62 years (mean 48.4), with mixed or conductive, bilateral or unilateral hearing loss were included in this study. Surgical intervention involved monaural implantation of the Med-El VSB between 2006 and 2009. The results were assessed using pure tone audiometry. In 5 years of experience with the technique, no significant complications or device extrusion were observed except for two revision surgeries requiring FMT repositioning. In the 3-year follow-up, we observed stable hearing in the implanted ear. It is concluded that direct round window stimulation without interposed fascia is an alternative for patients with hearing impairment caused by chronic otitis media and/or lack of ossicles, especially after modified radical mastoidectomy. It allows good results in a selected group of patients, although further observation on a larger population is needed to confirm long-term validity and effectiveness.